BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMENIS

    MDR report key: 3111671 · Received May 8, 2013

    Report

    Report Number
    MW5030130
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    July 18, 2012
    Report Date
    May 8, 2013
    Manufacturer
    LUMENIS INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I'VE SUSTAINED SERIOUS PIGMENT DAMAGE AND SCARRING THAT CONTINUES TO WORSEN EVEN TEN MONTHS FOLLOWING CO2 LASER RESURFACING ON MY ENTIRE CHEST, SHOULDERS AND FULL ARMS. MY SKIN IS COVERED WITH RED, PINK, BROWN AND WHITE PATCHES, ALONG WITH HUNDREDS OF LINES AND SCARS THAT RESEMBLE STRETCH MARKS. THIS HAS TOTALLY DISFIGURED MY APPEARANCE AND AM UNABLE TO DO LITTLE MORE THAN TRY TO MASK THE DAMAGE WITH HEAVY COVER MAKEUP PRODUCTS SUCH AS DERMABLEND. I'VE YET TO SEE ANY OF THE "HORROR STORY" PICTURES THAT EVEN COME CLOSE TO THE AMOUNT AND EXTENT OF THE DAMAGE I'VE REC'D. I'D HAD FRAXEL PERFORMED OVER A YR PRIOR TO TREAT AGING SKIN WITH GREAT RESULTS, SO I HAD NO FEAR OF LASER DAMAGE PRIOR TO THIS TREATMENT. ADD'L CO2 DONE ON SMALL TEST AREA ON STERNUM ON (B)(6) 2013 AT THE "LIGHTEST" SETTING. ONCE AGAIN PERFORMED CO2 ON A LIGHT SETTING OVER PREVIOUS TEST AREA, ALONG WITH A BIT LARGER "V" SHAPE - INCLUDING TEST AREA - ON LOWER CHEST ABOVE STERNUM. REASON FOR USE: TO TREAT AGING SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202307 LUMENIS FRACTIONATED CO2 LASER GEX LUMENIS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability